Rectal CancerNCT00182130
Quality Initiative in Rectal Cancer (QIRC) Trial
A study testing Quality Initiative in Rectal Cancer (QIRC) strategy in people with Rectal Cancer, run by Hamilton Health Sciences Corporation.
Trial summary
The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Quality Initiative in Rectal Cancer (QIRC) strategy
- Type of treatment
- Surgery or procedure
- How many people
- 691 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospital inclusion criteria:
- 1. An Ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998.
- Patient inclusion criteria:
- Consecutive patients at each participating site who underwent major rectal cancer surgery.
- Tumor located within 15 cm of anal verge by rigid sigmoidoscopy, or, at or below the level of the sacral promontory at the time of surgery.
Who cannot join
- -
About this study
The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.
Read the detailed description
Approximately 5000 Canadians are annually diagnosed with rectal cancer. For patients undergoing rectal cancer surgery two unfortunate outcomes are permanent colostomy and local tumor recurrence. Research demonstrates that in Ontario, Canada and other parts of the world the standard of care for rectal cancer surgery leaves room for improvement.
This is a multi-center trial that will test if a set of interventions designed to positively influence surgeon practice, titled the Quality Initiative in Rectal Cancer (QIRC) strategy, can improve rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients. Secondary outcomes to be assessed include sexual, bowel, and bladder function, and quality of life. The QIRC strategy consists of a workshop to discuss quality issues in rectal cancer, operative demonstration to demonstrate optimal surgical techniques, the use of opinion leaders, and a postoperative questionnaire designed to prompt surgeons to re-examine their key operative steps. The QIRC strategy is largely designed to teach total mesorectal excision, a new gold standard for rectal cancer surgery that has been shown in non-randomized studies to lower patient rates of permanent colostomy and local tumour recurrence.
Sixteen hospitals across the province of Ontario were allocated by cluster randomization to the QIRC strategy (experimental arm) versus minimal intervention (control arm). All hospitals are high-volume centres - an annual rectal cancer procedure volume of 15 or greater. Hospitals in the control arm represent the normal practice environment. Approximately 700 patients will be assessed. In addition to measuring rates of permanent colostomy and local recurrence of tumour, the study will examine bowel, bladder and sexual function, and overall quality of life among patients.
A positive trial - better results in hospitals that receive the intervention - may suggest that to effectively influence surgeon practice, resource intense approaches are necessary along with active buy-in from the surgical community.
- Conditions
- Rectal Cancer
- Being tested
- Quality Initiative in Rectal Cancer (QIRC) strategy
- Keywords
- rectal cancer, surgery, physician behaviour, knowledge translation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Initiative in Rectal Cancer (QIRC) strategyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital rate of permanent colostomy
Hospital rate of local recurrence
Secondary outcomes (2)
Bowel, bladder and sexual function
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2002
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 691 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Marko Simunovic, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182130
- Sponsor's protocol ID
- MCT-50013
- Status last verified
- Jul 2005
- First submitted
- 10 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Simunovic M, Coates A, Goldsmith CH, Thabane L, Reeson D, Smith A, McLeod RS, DeNardi F, Whelan TJ, Levine MN. The cluster-randomized Quality Initiative in Rectal Cancer trial: evaluating a quality-improvement strategy in surgery. CMAJ. 2010 Sep 7;182(12):1301-6. doi: 10.1503/cmaj.091883. Epub 2010 Aug 9.
PubMed 20696797
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Initiative in Rectal Cancer (QIRC) Trial
- ClinicalTrials.gov ID
- NCT00182130
- Acronym / sponsor ID
- MCT-50013
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, surgery, physician behaviour, knowledge translation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 691 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- May 2002
- Study completion
- Jun 2007
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Quality initiative in rectal cancer (QIRC) trial will test if a strategy designed to positively influence surgeon practice can decrease hospital rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients.
Detailed description
Approximately 5000 Canadians are annually diagnosed with rectal cancer. For patients undergoing rectal cancer surgery two unfortunate outcomes are permanent colostomy and local tumor recurrence. Research demonstrates that in Ontario, Canada and other parts of the world the standard of care for rectal cancer surgery leaves room for improvement.
This is a multi-center trial that will test if a set of interventions designed to positively influence surgeon practice, titled the Quality Initiative in Rectal Cancer (QIRC) strategy, can improve rates of permanent colostomy and local tumour recurrence for surgically treated rectal cancer patients. Secondary outcomes to be assessed include sexual, bowel, and bladder function, and quality of life. The QIRC strategy consists of a workshop to discuss quality issues in rectal cancer, operative demonstration to demonstrate optimal surgical techniques, the use of opinion leaders, and a postoperative questionnaire designed to prompt surgeons to re-examine their key operative steps. The QIRC strategy is largely designed to teach total mesorectal excision, a new gold standard for rectal cancer surgery that has been shown in non-randomized studies to lower patient rates of permanent colostomy and local tumour recurrence.
Sixteen hospitals across the province of Ontario were allocated by cluster randomization to the QIRC strategy (experimental arm) versus minimal intervention (control arm). All hospitals are high-volume centres - an annual rectal cancer procedure volume of 15 or greater. Hospitals in the control arm represent the normal practice environment. Approximately 700 patients will be assessed. In addition to measuring rates of permanent colostomy and local recurrence of tumour, the study will examine bowel, bladder and sexual function, and overall quality of life among patients.
A positive trial - better results in hospitals that receive the intervention - may suggest that to effectively influence surgeon practice, resource intense approaches are necessary along with active buy-in from the surgical community.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. An Ontario hospital with a procedure volume of 15 or more major rectal cancer resections per year for fiscal years 1996 to 1998.
- Consecutive patients at each participating site who underwent major rectal cancer surgery.
- Tumor located within 15 cm of anal verge by rigid sigmoidoscopy, or, at or below the level of the sacral promontory at the time of surgery.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality Initiative in Rectal Cancer (QIRC) strategy | Procedure or surgery | – |
Primary outcome
Hospital rate of permanent colostomy
Hospital rate of local recurrence
2 secondary outcomes
Bowel, bladder and sexual function
Quality of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
- Derived from this study: PubMed 20696797Simunovic M, Coates A, Goldsmith CH, Thabane L, Reeson D, Smith A, McLeod RS, DeNardi F, Whelan TJ, Levine MN. The cluster-randomized Quality Initiative in Rectal Cancer trial: evaluating a quality-improvement strategy in surgery. CMAJ. 2010 Sep 7;182(12):1301-6. doi: 10.1503/cmaj.091883. Epub 2010 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Simunovic, MD principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Quality Initiative in Rectal Cancer (QIRC) strategy in people with Rectal Cancer, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital rate of permanent colostomy. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2005.